pramipexole (Rx)

Brand and Other Names:Mirapex, Mirapex ER
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 0.125mg
  • 0.25mg
  • 0.5mg
  • 0.75mg
  • 1mg
  • 1.5mg

tablet, extended release

  • 0.375mg
  • 0.75mg
  • 1.5mg
  • 2.25mg
  • 3mg
  • 3.75mg
  • 4.5mg

Parkinson Disease

Immediate-release: 0.125 mg PO q8hr initially; gradually titrated upward at weekly intervals to target range of 1.5-4.5 mg/day PO divided q8hr

Extended-release: 0.375 mg/day PO initially; if necessary, may be increased every 5-7 days, first to 0.75 mg/day and then by increments of 0.75 mg/day; not to exceed 4.5 mg/day

Restless Legs Syndrome

0.125 mg/day PO 2-3 hr before bedtime initially; may be increased every 4-7 days up to 0.5 mg/day (every 14 days if CrCl 20-60 mL/min)

Dosage Modifications

Hepatic impairmet: No dosage adjustments provided in the manufacturer's labeling; adjustment not expected; undergoes minimal hepatic metabolism

Renal Impairment

Parkinson disease

  • Immediate release
    • CrCl >50 mL/min: Dosage adjustment not necessary
    • CrCl 30-50 mL/min: 0.125 mg twice daily initially; not to exceed 0.75 mg TID
    • CrCl 15-29 mL/min: 0.125 mg qDay; not to exceed 1.5 mg qDay
    • CrCl <15 mL/min: Dosage adjustment not provided in manufacturer's labeling; not studied
    • ESRD requiring hemodialysis: Dosage adjustment not provided in manufacturer's labeling; not studied
  • Extended release
    • CrCl >50 mL/min: Dosage adjustment not necessary
    • CrCl 30-50 mL/min: 0.375 every other day; may increase to 0.375 mg qDay no sooner than 1 wk after initiating therapy; may increase by 0.375 mg/dose not more frequently than every 7 days; not to exceed 2.25 mg qDay
    • CrCl <30 mL/min: Not recommended
    • ESRD requiring hemodialysis: Not recommended

Restless legs syndrome

  • Immediate release
    • CrCl >60 mL/min: Dosasge adjustment not necessary
    • CrCl 20-60 mL/min: Dosage adjustment not necessary but duration between titration should be increased to 14 days
    • CrCl<20 mL/min: Dosage adjustment not provided by manufacturer's labeling; not studied

Dosing Considerations

May switch overnight from immediate-release to extended-release tablets at same daily dose; dose adjustments may be required for some patients

Administration

Extended-release: Swallow whole; do not chew, crush, or divide

Discontinuing immediate- or extended-release: Taper off at a rate of 0.75 mg/day until the daily dose has been reduced to 0.75 mg; thereafter, the dose may be reduced by 0.375 mg/day

Dosage Forms & Strengths

tablet

  • 0.125mg
  • 0.25mg
  • 0.5mg
  • 0.75mg
  • 1mg
  • 1.5mg

tablet, extended release

  • 0.375mg
  • 0.75mg
  • 1.5mg
  • 2.25mg
  • 3mg
  • 3.75mg
  • 4.5mg

Tourette Syndrome (Orphan)

Treatment of Tourette syndrome in pediatric patients

Orphan indication sponsor

  • Boehringer-Ingelheim Pharmaceuticals, Inc; 900 Ridgebury Road; Ridgefield, CT 06877
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Interactions

Interaction Checker

and pramipexole

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (25)

              • aripiprazole

                aripiprazole decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • chlorpromazine

                chlorpromazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • clozapine

                clozapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • droperidol

                droperidol decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • fluphenazine

                fluphenazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • haloperidol

                haloperidol decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • iloperidone

                iloperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • loxapine

                loxapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • loxapine inhaled

                loxapine inhaled decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • metoclopramide

                metoclopramide decreases levels of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • metoclopramide intranasal

                pramipexole, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

                metoclopramide intranasal, pramipexole. dopaminergic effects. Avoid or Use Alternate Drug. Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (eg, parkinsonian symptoms) or decreased therapeutic effects of metoclopramide.

              • olanzapine

                olanzapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • paliperidone

                paliperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • perphenazine

                perphenazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • pimozide

                pimozide decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • prochlorperazine

                prochlorperazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • promethazine

                promethazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • quetiapine

                quetiapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • risperidone

                risperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • tafenoquine

                tafenoquine will increase the level or effect of pramipexole by Other (see comment). Avoid or Use Alternate Drug. Tafenoquine inhibits organic cation transporter-2 (OCT2) and multidrug and toxin extrusion (MATE) transporters in vitro. Avoid coadministration with OCT2 or MATE substrates. If coadministration cannot be avoided, monitor for substrate-related toxicities and consider dosage reduction if needed based on product labeling of the coadministered drug.

              • thioridazine

                thioridazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • thiothixene

                thiothixene decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • trifluoperazine

                trifluoperazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              • trilaciclib

                trilaciclib will decrease the level or effect of pramipexole by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.

              • ziprasidone

                ziprasidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

              Monitor Closely (20)

              • apomorphine

                apomorphine and pramipexole both increase dopaminergic effects. Use Caution/Monitor.

              • bromocriptine

                bromocriptine and pramipexole both increase dopaminergic effects. Use Caution/Monitor. Combining drugs may be therapeutic in patients with Parkinsonism.

              • cabergoline

                cabergoline and pramipexole both increase dopaminergic effects. Use Caution/Monitor.

              • cenobamate

                cenobamate, pramipexole. Either increases effects of the other by sedation. Use Caution/Monitor.

              • cimetidine

                cimetidine will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • clobazam

                pramipexole, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

              • clonidine

                clonidine, pramipexole. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.

              • digoxin

                digoxin will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • erdafitinib

                erdafitinib increases levels of pramipexole by decreasing renal clearance. Modify Therapy/Monitor Closely. Consider alternatives that are not OCT2 substrates or consider reducing the dose of OCT2 substrates based on tolerability.

              • levodopa

                levodopa and pramipexole both increase dopaminergic effects. Use Caution/Monitor.

              • lurasidone

                lurasidone decreases effects of pramipexole by Other (see comment). Use Caution/Monitor. Comment: Antipsychotics may diminish the therapeutic effect of anti-parkinson's agents; may increase riskof hypotension.

                lurasidone, pramipexole. Either increases toxicity of the other by sedation. Use Caution/Monitor. Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

              • methyldopa

                methyldopa and pramipexole both increase dopaminergic effects. Use Caution/Monitor.

              • methylphenidate

                pramipexole, methylphenidate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Potential for additive CNS stimulation.

              • midazolam intranasal

                midazolam intranasal, pramipexole. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • procainamide

                pramipexole will increase the level or effect of procainamide by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • quinidine

                quinidine will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • ropinirole

                pramipexole and ropinirole both increase dopaminergic effects. Use Caution/Monitor.

              • solriamfetol

                pramipexole and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • stiripentol

                stiripentol, pramipexole. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

              • tenofovir DF

                tenofovir DF increases levels of pramipexole by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .

              Minor (6)

              • isavuconazonium sulfate

                isavuconazonium sulfate will increase the level or effect of pramipexole by Other (see comment). Minor/Significance Unknown. Isavuconazonium sulfate, an OCT2 inhibitor, may increase the effects or levels of OCT2 substrates.

              • memantine

                memantine will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methyclothiazide

                methyclothiazide will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • quinine

                pramipexole will increase the level or effect of quinine by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • triamterene

                pramipexole will increase the level or effect of triamterene by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • verapamil

                pramipexole will increase the level or effect of verapamil by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.

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              Adverse Effects

              Some variations between early Parkinson, advanced Parkinson, and restless legs syndrome

              Incidence of some adverse drug reactions (eg, dizziness, accidental injury) >10% but comparable to placebo

              >10%

              Somnolence

              Dyskinesia

              Hallucinations

              Insomnia

              Dizziness

              Postural hypotension

              Nausea

              Constipation

              1-10% (partial list)

              Abnormal dreams, thoughts, or vision

              Amnesia

              Confusion

              Paranoia or delusion

              Akathisia

              Asthenia

              Dry mouth

              Urinary frequency

              Postmarketing Reports

              Neurologic: Abnormal behavior, abnormal dreams, compulsive shopping, fatigue, hallucinations (all kinds), headache, pathologic gambling

              Cardiovascular: Hypotension (including syncope and postural hypotension)

              Metabolic: Increased eating (including binge eating, compulsive eating, and hyperphagia), weight gain, SIADH

              Dermatologic: Skin reactions, including rythema, rash, pruritus, urticaria

              Gastrointestinal: Vomiting

              Genitourinary: Libido disorders (including increased or decreased libido and hypersexuality)

              Withdrawal symptoms

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              Warnings

              Contraindications

              Hypersensitivity

              Cautions

              May cause sudden daytime "sleep attacks;" inquire about factors that may increase risk of falling asleep, including sleep disorders or taking sedating medications; caution patients about performing tasks requiring mental alertness; discontinue if there is evidence of sleep attacks; if decision is made to continue therapy, advice patient not to perform dangerous activities requiring mental alertness

              Orthostatic hypotension may occur, particularly during dose escalation; monitor closely Parkinson patients being treated with dopaminergic agonists, especially during dose escalation

              In early Parkinson, dosages higher than 1.5 mg q8hr provided no additional benefit but increased adverse events

              Use with caution in renal impairment; dose adjustment may be necessary; do not administer extended release tablets to patients with CrCl<30 mL/min or ESRD requiring hemodialysis

              Augmentation or rebound of restless legs syndrome (RLS) may occur with therapy in RLS patients

              The elderly may be more prone to adverse effects

              Swallow whole; do not chew, crush, or divide extended release tablets

              Events reported with dopaminergic therapy include hyperpyrexia and confusion

              Fibrotic complications reported with use; monitor closely for signs and symptoms of fibrosis; discontinuation of therapy may resolve complications but not in all cases

              Rsk of melanoma increases in Parkinson disease patients; monitor closely and perform periodic skin examination

              Pathologic degenerative changes observed in retinas of albino rats during studies; significance in humans unclear

              May cause or exacerbate dyskinesia; use with caution in patients with preexisting dyskinesias

              Symptoms resembling neuroleptic malignant syndrome, including elevated temperature, muscular rigidity, altered consciousness, and autonomic instability reported with rapid dose reduction, discontinuation, or changes in therapy; taper dose to decrease risk of hyperpyrexia and confusion

              Risk of new-onset heart failure undergoing FDA evaluation (FDA safety announcement 9/19/2012)

              Withdrawal symptoms

              • Gradual discontinuance required over period of 1 week or longer; symptoms resembling neuroleptic malignant syndrome may occur on abrupt withdrawal
              • Symptoms including apathy, anxiety, depression, fatigue, insomnia, sweating, and pain reported during taper or after discontinuation of dopamine agonists; these symptoms generally do not respond to levodopa
              • Prior to discontinuation, patients should be informed about potential withdrawal symptoms, and monitored during and after discontinuation; in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at lowest effective dose may be considered

              Psychiatric effects

              • Patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, binge eating, and/or other intense urges and the inability to control these urges while taking one or more of the medications, that increase central dopaminergic tone
              • Patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during treatment or after starting or increasing the dose
              • Other drugs prescribed to improve the symptoms of Parkinson’s disease or RLS can have similar effects on thinking and behavior; this abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, symptoms of mania (eg, insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, and delirium
              • Risk increases with age; dose reduction or discontinuation may reverse these behaviors but not in all cases
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              Pregnancy & Lactation

              There are no adequate data on the developmental risk associated with therapy in pregnant women; no adverse developmental effects reported in animal studies in which pramipexole was administered to rabbits during pregnancy; effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures

              In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively; background risk of major birth defects and miscarriage for the indicated population is unknown

              Lactation: Not known if drug secreted in breast milk; may inhibit milk production; discontinue drug, or do not nurse

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Non-ergot dopamine D2 receptor agonist; strong affinity for D2 and D3 receptors; binding to these receptors increases dopamine activity on nerves of striatum and substantia nigra

              Absorption

              Bioavailability: >90%

              Peak plasma time: Immediate release, 2 hr; extended release, 6 hr

              Distribution

              Protein bound: 15%

              Vd: 500 L

              Metabolism

              <10% metabolized

              Elimination

              Half-life: 8.5 hr (12 hr in elderly)

              Renal clearance: 400 mL/min

              Excretion: Urine (90%)

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Mirapex ER oral
              -
              1.5 mg tablet
              Mirapex ER oral
              -
              0.75 mg tablet
              Mirapex ER oral
              -
              3.75 mg tablet
              Mirapex ER oral
              -
              2.25 mg tablet
              Mirapex ER oral
              -
              4.5 mg tablet
              Mirapex ER oral
              -
              3 mg tablet
              Mirapex ER oral
              -
              0.375 mg tablet
              pramipexole oral
              -
              0.25 mg tablet
              pramipexole oral
              -
              0.125 mg tablet
              pramipexole oral
              -
              0.125 mg tablet
              pramipexole oral
              -
              0.5 mg tablet
              pramipexole oral
              -
              1 mg tablet
              pramipexole oral
              -
              0.5 mg tablet
              pramipexole oral
              -
              3.75 mg tablet
              pramipexole oral
              -
              0.125 mg tablet
              pramipexole oral
              -
              0.25 mg tablet
              pramipexole oral
              -
              0.5 mg tablet
              pramipexole oral
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              1 mg tablet
              pramipexole oral
              -
              1.5 mg tablet
              pramipexole oral
              -
              0.75 mg tablet
              pramipexole oral
              -
              1 mg tablet
              pramipexole oral
              -
              0.25 mg tablet
              pramipexole oral
              -
              0.125 mg tablet
              pramipexole oral
              -
              1.5 mg tablet
              pramipexole oral
              -
              0.25 mg tablet
              pramipexole oral
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              0.75 mg tablet
              pramipexole oral
              -
              3 mg tablet
              pramipexole oral
              -
              1.5 mg tablet
              pramipexole oral
              -
              4.5 mg tablet
              pramipexole oral
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              3 mg tablet
              pramipexole oral
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              1.5 mg tablet
              pramipexole oral
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              0.375 mg tablet
              pramipexole oral
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              0.75 mg tablet
              pramipexole oral
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              1 mg tablet
              pramipexole oral
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              0.25 mg tablet
              pramipexole oral
              -
              1.5 mg tablet
              pramipexole oral
              -
              4.5 mg tablet
              pramipexole oral
              -
              0.375 mg tablet
              pramipexole oral
              -
              0.75 mg tablet
              pramipexole oral
              -
              0.5 mg tablet
              pramipexole oral
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              2.25 mg tablet
              pramipexole oral
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              1.5 mg tablet
              pramipexole oral
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              1.5 mg tablet
              pramipexole oral
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              1 mg tablet
              pramipexole oral
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              0.5 mg tablet
              pramipexole oral
              -
              0.125 mg tablet
              pramipexole oral
              -
              0.75 mg tablet
              pramipexole oral
              -
              1 mg tablet
              pramipexole oral
              -
              1.5 mg tablet
              pramipexole oral
              -
              0.125 mg tablet
              pramipexole oral
              -
              1.5 mg tablet
              pramipexole oral
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              0.25 mg tablet
              pramipexole oral
              -
              0.5 mg tablet
              pramipexole oral
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              0.375 mg tablet
              Mirapex oral
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              0.75 mg tablet
              Mirapex oral
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              0.25 mg tablet
              Mirapex oral
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              1 mg tablet
              Mirapex oral
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              0.5 mg tablet
              Mirapex oral
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              1.5 mg tablet
              Mirapex oral
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              0.125 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              pramipexole oral

              PRAMIPEXOLE - ORAL

              (pram-ih-PEX-ole)

              COMMON BRAND NAME(S): Mirapex

              USES: Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome").This medication is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep.Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

              HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking pramipexole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with or without food, as directed by your doctor. Taking this medication with food may lessen nausea. To reduce your risk of side effects (such as drowsiness, low blood pressure), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or take it more often than directed.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used pramipexole for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.If you temporarily stop taking this medication, you may need to start this medication again at a low dose and gradually increase your dose. Talk with your doctor about how to restart this medication.It may take a few weeks for the effects of this medication to be noticed. Tell your doctor if your condition does not get better or if it gets worse.

              SIDE EFFECTS: Nausea, dizziness, drowsiness, lightheadedness, trouble sleeping, constipation, headache, or dry mouth may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fainting, mental/mood changes (such as confusion, agitation, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), increased difficulty moving/walking, muscle cramps/spasm, unusual posture changes (such as the neck or body bending forward), restlessness, decreased sexual ability, increased shakiness (tremor)/stiffness, swelling of the ankles/feet.Get medical help right away if you have any very serious side effects, including: chest pain, fever, unusually fast/slow/irregular heartbeat, muscle pain/weakness, unusual tiredness, signs of kidney problems (such as change in the amount of urine), vision changes.Some people taking pramipexole have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with pramipexole even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (e.g., irregular heartbeat, heart failure), kidney problems, mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), sleep disorder (e.g., sleep apnea, narcolepsy).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at a greater risk for dizziness and hallucinations while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug may pass into breast milk and could have undesirable effects on a nursing infant. It may also affect milk production. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antipsychotics (such as chlorpromazine, haloperidol, thiothixene), cimetidine, metoclopramide.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). If you are taking this drug to treat Parkinson's disease, tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
              Additional Offers
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.